Novartis 'in negotiations' over price of Lucentis in UK

New study suggests off-label treatment with Roche's Avastin could be as effective as using Novartis' eye drug

Controversy surrounding the treatment of age-related macular degeneration (AMD) continues to rumble on in the UK, with the debate centred on the results of a study which suggested that off-label treatment with Roche's Avastin is as effective as Novartis' approved AMD medicine Lucentis, and with a much lower price tag.

In the latest development, Novartis has hinted that it may consider reducing the price of its drug if it can get approval for broader reimbursement on the UK National Health Service (NHS).

The publicly-funded IVAN trial hit the headlines over the weekend when it suggested that after a year's treatment, Avastin (bevacizumab) was just as effective as Lucentis (ranibizumab) in treating patients with the wet form of AMD, and could save the NHS £84.5m per annum.

Both drugs were developed by Roche subsidiary Genentech, and both target vascular endothelial growth factor (VEGF). However, at UK NHS prices Lucentis costs £741 per vial, compared to just £40 for Avastin.

Roche has said it has no intention of developing an AMD indication for Avastin, according to the UK's Nation Institute for Clinical Excellence and Healthcare (NICE), presumably because it has invested in a comprehensive clinical trials programme for Lucentis to show that it can be safely administered into the eye.

Novartis meanwhile has said there are serious safety concerns associated with the use of unlicensed Avastin in AMD, and has initiated legal proceedings against the NHS in a bid to stop doctors offering it as an option instead of Lucentis.

All told, 610 people were tested in the IVAN study, which also concluded that wet AMD patients could achieve similar responses when treatment was given only as required, rather than once per month as stipulated on Lucentis' labelling. At the end of the treatment period, the test subjects exhibited almost identical levels of vision regardless of the treatment option.

The researchers from 23 hospitals and UK universities say that their results back up data from an earlier US study - called CATT - which came to similar conclusions.

Novartis has previously maintained that aside from the data on efficacy, the CATT results also reveal a 30 per cent higher risk of adverse events with Avastin compared to Lucentis, including serious reactions such as arterio-thrombotic events, systemic haemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death.

While IVAN found no difference between the two drugs in terms of side effects, Novartis said this was "unsurprising, as IVAN is underpowered in relation to safety and not designed to demonstrate differences between the two drugs".

The company may have its work cut out convincing doctors that the increase in risk justifies the huge price differential, and there are some preliminary signs that it may be prepared to negotiate with the UK authorities on the pricing of Lucentis.

In a statement, the company said it is in discussions with both NICE and the Department of Health "regarding options looking at the cost effectiveness of [the drug] across all its approved indications”.